A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01058863
First received: January 27, 2010
Last updated: May 19, 2015
Last verified: May 2015
  Purpose

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.


Condition Intervention Phase
Asthma
Drug: Albuterol Spiromax®
Drug: ProAir® HFA
Other: Placebo Inhaler
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, 5-way Crossover, Multicenter, Single-dose, Dose-ranging Study to Compare the Efficacy and Safety of Albuterol Spiromax® and ProAir® HFA in Adult and Adolescent Subjects Ages 12 and Older With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) [ Time Frame: Day 1 up to Day 30 ] [ Designated as safety issue: No ]

    FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.

    The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.



Secondary Outcome Measures:
  • Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6) [ Time Frame: Day 1 up to Day 30 ] [ Designated as safety issue: No ]

    Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values.

    The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.


  • Participants With Treatment-Emergent Adverse Events [ Time Frame: Day 1 up to Day 37 ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.


Enrollment: 72
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albuterol Spiromax® 90 mcg
A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
Drug: Albuterol Spiromax®
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Name: ProAir® RespiClick, Albuterol multi-dose dry powder inhaler (MDPI)
Other: Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Experimental: Albuterol Spiromax® 180 mcg
A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
Drug: Albuterol Spiromax®
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Name: ProAir® RespiClick, Albuterol multi-dose dry powder inhaler (MDPI)
Other: Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Active Comparator: ProAir® HFA 90 mcg
A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
Drug: ProAir® HFA
ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Name: albuterol HFA-MDI
Other: Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Active Comparator: ProAir® HFA 180 mcg
A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
Drug: ProAir® HFA
ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Other Name: albuterol HFA-MDI
Other: Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Placebo Comparator: Placebo Inhaler
Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
Other: Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must provide written informed consent,
  • Be between 12 years of age and older,
  • Male or Female, females of non-child bearing potential or using reliable contraception
  • Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
  • Stable low dose of Inhaled Corticosteroids
  • Non-smoker, 12 months smoking-free and <=10-pack years history
  • Otherwise healthy
  • Other criteria apply

Exclusion Criteria:

  • Pregnant
  • Allergic to albuterol or severe milk protein allergy
  • Must not be on another trial for 30days.
  • Other criteria apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058863

Locations
United States, California
Teva Clinical Study Site
Huntington Beach, California, United States, 92647
Teva Clinical Study Site
Rolling Hills Est., California, United States, 90274
Teva Clinical Study Site
San Diego, California, United States, 92123
United States, Colorado
Teva Clinical Study Site
Colorado Springs, Colorado, United States, 080907
United States, Florida
Teva Clinical Study Site
Margate, Florida, United States, 33036
Teva Clinical Study Site
Miami, Florida, United States, 33173
United States, Missouri
Teva Clinical Study Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
Teva Clinical Study Site
Skillman, New Jersey, United States, 08558
United States, North Carolina
Teva Clinical Study Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Teva Clinical Study Site
Cincinnati, Ohio, United States, 45231
Teva Clinical Study Site
Dayton, Ohio, United States, 45406
United States, Oregon
Teva Clinical Study Site
Medford, Oregon, United States, 97504
Teva Clinical Study Site
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Study Leader Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01058863     History of Changes
Other Study ID Numbers: ABS-AS-201
Study First Received: January 27, 2010
Results First Received: May 19, 2015
Last Updated: May 19, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Procaterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on July 30, 2015